WASHINGTON: The US Food and Drug Administration on Friday approved a highly anticipated new drug designed to slow cognitive decline in patients in the early stages of Alzheimer’s disease.
The FDA approval of the drug, Leqembi, also known as lecanemab, came just days after the agency was harshly criticized in a congressional report for its green-lighting of another Alzheimer’s drug, Aduhelm.
And it was granted despite trial results showing the monoclonal antibody treatment carries risks of brain swelling and bleeding.
Both drugs were approved by the FDA through an accelerated process that allows the US regulatory agency to fast-track approval of drugs for serious conditions where there is an unmet medical need.
Leqembi and Aduhelm, which were both jointly developed by Japan’s Eisai and Biogen of the United States, “represent an important advancement in the ongoing fight to effectively treat Alzheimer’s disease,” the FDA said in a statement.
“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” Billy Dunn of the FDA’s Center for Drug Evaluation and Research said in a statement.
Leqembi is “the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease,” Dunn said.
Preliminary data from a trial of Leqembi was released in September and found it slowed cognitive decline in Alzheimer’s patients by 27 percent.
The phase three trial involved nearly 1,800 people, divided between those given the drug and given a placebo, and ran over 18 months.
The complete trial data, published in the New England Journal of Medicine, fleshed out the findings but also raised concern about the incidence of “adverse effects” including brain bleeds and swelling.
The results showed that 17.3 percent of patients administered the drug experienced brain bleeds, compared with nine percent of those receiving a placebo.
And 12.6 percent of those taking the drug experienced brain swelling, compared with just 1.7 percent of those in the placebo group.
Deaths were reported at approximately the same rate in both arms of the trial of the drug.
In Alzheimer’s disease, two key proteins, tau and amyloid beta, build up into tangles and plaques, known together as aggregates, which cause brain cells to die and lead to brain shrinkage.
Leqembi works by targeting amyloid.
Biogen and Eisai previously brought Aduhelm to market, but there was significant controversy over whether it worked, and its approval in 2021 led to three high-level resignations in the FDA.
An 18-month US congressional investigation said the approval process for Aduhelm was “rife with irregularities” and criticized both the agency and Biogen.
The Cambridge, Massachusetts-based Biogen set an “unjustifiably high price” for Aduhelm of $56,000 a year, the congressional report said.
Eisai said Leqembi would be priced initially at $26,500 per year.
US approves new drug to treat Alzheimer’s
https://arab.news/8eh7g
US approves new drug to treat Alzheimer’s
- Leqembi is “the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease”.
Nikki Haley writes ‘finish them’ on Israeli shell: lawmaker
WASHINGTON: Former US presidential hopeful Nikki Haley has been photographed writing “Finish Them” on an Israeli shell as she toured sites near the northern border with Lebanon.
The photograph was posted on X on Tuesday by Danny Danon, a member of the Israeli parliament and former ambassador to the United Nations, who was accompanying Haley on her visit.
“’Finish Them’. This is what my friend the former ambassador Nikki Haley wrote,” Danon said in his post that showed a kneeling Haley writing on a shell with a purple marker pen.
Haley was a hawkish UN envoy under Donald Trump, and her term overlapped with Danon.
The Gaza war was sparked by Hamas’s October 7 attack on southern Israel, which resulted in the deaths of 1,189 people, mostly civilians, according to an AFP tally based on the latest Israeli official figures.
Militants also took 252 hostages, 121 of whom remain in Gaza, including 37 the army says are dead.
Israel’s retaliatory offensive has killed at least 36,096 people in Gaza, mostly civilians, according to the territory’s health ministry.
Haley, 52, abandoned her White House bid in March after heavy defeats in Republican primary contests to Trump, and last week said that she would vote for him in the election.
Trump has ruled her out of contention to be his vice president, but she is a potential presidential runner in 2028.
The White House said Tuesday that President Joe Biden has no plans to change his Israel policy following a deadly weekend strike on Rafah but that he is not turning a “blind eye” to the plight of Palestinian civilians.
White House says still opposes Ukraine using US arms against Russia
WASHINGTON: The White House on Tuesday rejected Ukrainian President Volodymyr Zelensky’s pleas for an end to restrictions on Kyiv using US-supplied arms to strike Russian territory.
“There’s no change to our policy at this point. We don’t encourage or enable the use of US-supplied weapons to strike inside Russia,” National Security Council spokesman John Kirby told a briefing.
Prosecutor urges jury to convict Trump, citing ‘powerful evidence’
NEW YORK: Donald Trump engaged in “conspiracy and a cover-up” to hide from voters that he had paid hush money to a porn star, prosecutors told a jury Tuesday in closing arguments at the first ever criminal trial of a former US president.
Less than six months before an election in which Trump is seeking to return to the White House, the stakes riding on the verdict are high — both for the 77-year-old personally and for the country.
Trump is accused of falsifying business records to reimburse his ex-lawyer Michael Cohen for a $130,000 payment to adult film actress Stormy Daniels, afraid that her account of an alleged sexual encounter could doom his 2016 presidential campaign against Hillary Clinton.
Assistant District Attorney Joshua Steinglass delivered the summation for the prosecution after Trump’s defense lawyer, Todd Blanche, called for his acquittal, insisting the case against the former president was based on lies.
Steinglass said Daniels’s story about her 2006 tryst with the married Trump was the motive for the alleged crime, but the “case at its core is about a conspiracy and a cover up” on the eve of an election.
“The people have presented powerful evidence of the defendant’s guilt,” he said.
Blanche told the jury that Trump was “innocent.” The only outcome should be a “very quick and easy not guilty verdict.”
Cohen, the one-time Trump fixer who became the star prosecution witness, was motivated by “outright hatred” for his former boss, Blanche said.
“He told you a number of things on that witness stand that were lies, pure and simple,” he said.
Blanche said Trump was busy “running the country” when the reimbursements were made to Cohen and he did not closely inspect all the invoices that came across his desk.
“There was no intent to defraud and beyond that there was no conspiracy to influence the 2016 election,” Blanche said.
But Steinglass countered that there was a mountain of corroborating evidence in addition to Cohen’s testimony.
“They want to make this case about Michael Cohen,” he said. “This case is about Donald Trump and whether he should be accountable for causing false entries in his own business records and whether he did that to cover up his own election violations.”
Speaking to reporters before entering the Manhattan courtroom, Trump called it a “very dangerous day for America.”
“We have a rigged court case that should have never been brought,” he said as three of his five children — Don Jr, Eric and Tiffany — stood behind him.
The 12 anonymous jurors were to start deliberations as early as Wednesday.
Polls show Trump neck and neck against President Joe Biden and the verdict will inject new tension into the White House race.
Speaking on behalf of the Biden campaign outside court, legendary actor Robert De Niro berated Trump as a “clown” intent on destroying the country.
The first former or sitting president under criminal indictment, Trump faces charges ranging from the relatively minor hush money case to accusations he took top secret documents and tried to overthrow the 2020 election.
The New York case, which featured more than 20 witnesses over five weeks and gripping testimony by Daniels and Cohen, is the only one likely to come to trial by election day.
If convicted, Trump faces up to four years in prison on each of 34 counts, but legal experts say that as a first-time offender he is unlikely to get jail time.
A conviction would not bar him from appearing on the ballot in November.
Trump chose not to testify in his defense.
Instead, he used his trips to court to stage tirades against “corrupt” Judge Juan Merchan, and to claim the trial is a Democratic ploy to keep him off the campaign trail.
To return a guilty or not guilty verdict requires the jury to be unanimous. Just one holdout means a hung jury and a mistrial, although prosecutors could seek a new trial.
Biden’s blurred red lines under scrutiny after Rafah carnage
WASHINGTON: Joe Biden’s red lines over Israel’s assault on Rafah have kept shifting, but the US president faces growing pressure to take a firmer stance after a deadly strike in the Gazan city.
Despite global outrage over the attack in which 45 people were killed, the White House insisted on Tuesday that it did not believe Israel had launched the major operation that Biden has warned against.
John Kirby, the US National Security Council spokesman, said that Biden had been consistent and was not “moving the stick” on what defined an all-out military offensive by key ally Israel.
But Biden faces a difficult balancing act both domestically and internationally over Gaza, especially in a year when the 81-year-old Democrat is locked in an election battle with Donald Trump.
“Biden wants to appear tough on Rafah, and has really tried to be stern with (Israeli Prime Minister Benjamin) Netanyahu, but in an election year, his red lines are increasingly blurred,” Colin Clarke, director of research at the Soufan Group, told AFP.
“I think he’ll continue shifting those lines, ducking and weaving, largely in response to events on the ground.”
Facing US campus protests over his support for Israel, Biden said earlier this month that he would not supply Israel with weapons for a major military operation in Rafah, and he halted a shipment of bombs.
Yet he has since taken no action even as Israel has stepped up air attacks and, as of Tuesday, moved tanks into central Rafah.
Instead, the White House has largely retreated to arguing about what does, and does not, constitute an invasion.
National Security Adviser Jake Sullivan said last week there was “no mathematical formula” and said that “what we’re going to be looking at is whether there is a lot of death and destruction.”
At the White House on Tuesday, his colleague Kirby faced intense questioning over the Israeli strike, which sparked a fire at a displaced persons camp in which dozes of people burned to death.
Kirby said the deaths were “heartbreaking” and “horrific” but again said there would be no change in policy toward Israel.
“We have not seen them smash into Rafah,” he said.
“We have not seen them go in with large units, large numbers of troops, in columns and formations in some sort of coordinated maneuver against multiple targets on the ground.”
But internationally the pressure is growing on Biden, a self-described Zionist who has stuck by Netanyahu despite deep disagreements since the war began with the October 7 Hamas attack.
Questions are mounting over how long the United States can tolerate an Israeli assault on Rafah when the International Court of Justice — the UN’s top court, of which both the US and Israel are members — ordered it to stop.
Political pressure is also mounting on Biden at home.
Protests against his support for Israel have roiled university campuses across the United States, while many on the left wing of his Democratic Party also oppose his stance.
Republicans however have assailed Biden over what they say is his faltering support for Israel, with US House Speaker Mike Johnson inviting Netanyahu to address Congress.
“It is indeed a difficult balancing act,” Gordon Gray, a former US ambassador who is now a professor at George Washington University, told AFP.
“Threading the proverbial needle — as the Biden administration is apparently seeking to do — will only disappoint voters who feel strongly about the issue one way or another.”
Gray however said he believed Biden’s decades-old support for Israel meant he would unlikely change his position, saying he was a “rare politician who is acting out of genuine conviction rather than for his own electoral benefit.”
Deputy leader of UK’s Labour Party promises to fight to end Gaza’s suffering, in leaked video
- Labour, if elected, would recognize Palestinian statehood, says Angela Rayner
LONDON: Angela Rayner, the deputy leader of the UK’s Labour Party, has promised that her party will do everything in its power to ease the suffering in Gaza as it bids to regain Muslim voters’ support, a leaked video surfacing on social media has revealed.
The footage was first reported by the political blog Guido Fawkes, which claimed to have obtained the leaked tape from a meeting in Ashton-under-Lyne, Rayner’s constituency.
The MP is seen appealing to voters upset with the party’s stance on Israel’s assault on Gaza, The Telegraph reported.
Rayner — claiming she worked “day and night” to get three British doctors out of Rafah and is now attempting to secure aid for the enclave — said: “I promise you, the Labour Party, including myself, is doing everything we can, because nobody wants to see what’s happening.”
She acknowledged the party’s current inability to halt the fighting, admitting that Labour’s influence would be “limited,” even if it came to power after July’s general election.
Rayner added: “Only last week the Labour Party were supporting the ICC (International Criminal Court). The Conservatives didn’t support the ICC, so with this general election on that issue, we can’t affect anything when we’re not in government.
“And I’ll be honest with you, if Labour gets into government, we are limited. I will be honest. I’m not going to promise you … because (Joe) Biden, who’s the US (president), who has way more influence, has only got limited influence in that.
“And Qatar, Saudi Arabia, all of these people, we are all working to stop what’s happening at the moment; we want to see that. So I promise you, that’s what we want to see.”
Rayner also promised that, if Labour was elected, the party would recognize Palestinian statehood.
She added: “If Labour gets into power, we will recognize Palestine. I will push not only to recognize … there is nothing to recognize at the moment, sadly. It’s decimated.
“We have to rebuild Palestine; we have to rebuild Gaza. That takes more than just recognizing it.”
Gaza has been a divisive issue for Labour since Oct. 7, with reports revealing that Muslim voters have abandoned the party as a result of what they perceive as its politicians enabling the war.
The Telegraph found that Labour’s support had dropped in local elections in areas with large Muslim populations, including Oldham in Greater Manchester, where the party lost control of the council in a surprise defeat.
Labour leader Keir Starmer has expressed his determination to re-establish trust among those who have abandoned his party due to his handling of the Gaza war.
However, when probed on particular commitments, he remained vague.
Rayner said in the video: “I know that people are angry about what’s happening in the Middle East.
“If my resignation as an MP now would bring a ceasefire, I would do it. I would do it if I could effect change.”
However, she said such an eventuality was not “in my gift” due to the “failure of the international community.”
In response to the footage, Nigel Farage, Reform UK’s honorary president, accused Rayner of “begging” for the Muslim vote, The Telegraph reported.
